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Morbid ObesityNCT03982823

Comparison of Stapled and Hand-Sewn Sleeve Gastrectomy

A study testing Hand-Sewn Sleeve Gastrectomy and Stapled Sleeve Gastrectomy in people with Morbid Obesity, run by Inonu University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Sleeve gastrectomy is a stapler dependent bariatric procedure. A hand-sewn sleeve gastrectomy can be necessary under certain circumstances. Here, the investigatorsaimed to compare the outcomes of hand-sewn and stapled sleeve gastrectomies for the first time. Read more about this study

Who is it for?
Ages 21 to 54 years
Conditions the study is for
Morbid Obesity
What is being tested?
Hand-Sewn Sleeve Gastrectomy and Stapled Sleeve Gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
No sites listed yet
Study dates
1 May 2014to 31 Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 54 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Clinical diagnosis of morbid obesity (body mass index over 40 kg/m2)
  • Bariatric surgery must be the final decision of the obesity council.

Who cannot join

  • Patients under legal age (<18 years)

About this study

Official title: Comparison of Stapled and Hand-Sewn Sleeve Gastrectomy, Retrospective Study

Sleeve gastrectomy is a stapler dependent bariatric procedure. A hand-sewn sleeve gastrectomy can be necessary under certain circumstances. Here, the investigatorsaimed to compare the outcomes of hand-sewn and stapled sleeve gastrectomies for the first time.

In the hand-sewn group, no staplers were used and after vertical resection of the stomach by energy devices, the remnant stomach was closed by two rows intracorporeal sutures. In the stapler group, sleeve gastrectomy was done in the usual way.

Read the detailed description

Nowadays, morbid obesity is a major health problem that the investigatorsface in every age groups. In the treatment of morbid obesity, sleeve gastrectomy is applied more and more frequently. However, sleeve gastrectomy is a stapler dependent operation and sleeve gastrectomy without the use of staplers was very limited in the literature [1]. Hand-sewn sleeve gastrectomy can rarely be necessary in some special conditions such as technical defects of the staplers, patients allergies to titanium clips or sometimes when staplers were unusable [1]. As far as the investigatorsknow, there was no study that compare the results of stapled and hand-sewn sleeve gastrectomies so far. The purpose of this study was to compare the hand-sewn and stapled sleeve gastrectomies in a small case series.

In June 2013, the investigatorslaunched a natural orifice surgery program including several procedures. In this context, the investigatorsplanned natural orifice (transoral) extraction of sleeve gastrectomy specimens. Patients who were eligible and agree with participation to the hand-sewn sleeve gastectomy combine with transoral specimen extraction study were accepted to two group. This study is conducted according to the STROCSS criteria. Total six morbidly obese patients (body mass index more than 40 kg/m2) who had undergone hand-sewn sleeve gastrectomy between the dates May-2014 and December 2014, were investigated retrospectively. In the same time period, seven another morbidly obese patients included in the control group were treated with stapled sleeve gastrectomies. Grouping was done by the acceptance of the patients. The hand-sewn sleeve gastrectomy group combined with natural orifice surgery. Patients who do not participate the hand-sewn group were treated by the stapled sleeve gastrectomy and the specimens were extracted through the trocar site. In both groups, patients' age, gender, height, weight, body mass index, comorbidity, and lifestyle properties were recorded. Intraoperative blood loss, operating time, length of hospital stay, postoperative complications, and the metabolic/bariatric results of the two groups in one and three years were evaluated. Statistical comparisons were performed with nonparametric statistical tests (Mann-Whitney U-test and Wilcoxon Signed Rank Test to analyze numerical data, and Fisher exact test to analyze cathegorical data). Numerical data expressed as median and range. P<0.05 was considered as significant.

In the hand-sewn group, following pneumoperitoneum with a Veres needle, the first 5 mm trocar was entered 14 cm down and 4 cm left from the xyphoid process. Other two 5 mm trocars were applied to the left and right upper quadrant. Last two 5 mm trocars were placed just below the xyphoid process for automatic liver retractor and through the epigastrium as a working port. A 5 mm 300 optic camera was used and the intraabdominal pressure was set to 14 mmHg. Gastrocolic and gastrosplenic ligaments were divided by 5 mm Ligasure (Force Triad, Covidien, Boulder, CO, USA) starting from 4-6 cm to pylorus till the angle of His. The greater curvature was liberated up to the left crus of the diaphragm. The anterior and posterior wall of the stomach were transected with a 5 mm Ligasure device under the guidance of a 36 F bougie, starting 4-6 cm away from the pylorus and division of both gatric leaves headed vertically in the direction of angle of His. After completion of the gastric division, the resected specimen was removed through the mouth with the help of an intraoperative peroral endoscopy using an endoscopic snare. The remaining open anterior and posterior walls of the stomach was continiously sutured each other by 3/0 polypropylene sutures. The suture length was 20 cm.

All the trocars were 5 mm in size in the hand-sewn group. The surgical technique of the stapled group has been defined in detail before (2). In short, vertical gastrectomy was applied with a 60 mm. lineer stapler (Endo GIATM Ultra, Covidien) under the guidance of 36 F bougie. These procedures were done through three 12 mm and two 5 mm trocars, that were placed to the same locations with the hand-sewn group. The specimen in the stapler group were extracted from the left upper quadrant trocar site. No supportive material or suture was use to the staple lines. Methylene blue test was done and a drain was place in all case.

After 6-8 hours postoperatively, the patients were mobilized, thromboembolic stockings were kept for five days. A liquid diet was started on day one. Prophylaxis of deep vein thrombosis was continued for 15 days.

Conditions
Morbid Obesity
Being tested
Hand-Sewn Sleeve Gastrectomy, Stapled Sleeve Gastrectomy
Keywords
morbid obesity, surgical stapling, suture techniques, natural orifice surgery, transoral, mini-laparoscopy
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hand-Sewn Sleeve GastrectomyProcedure or surgery

    After laparoscopic sleeve gastrectomy, gastrectomy site is hand-sewn with 3/0 polypropylene suture and the specimen is removed transorally.

  • Stapled Sleeve GastrectomyProcedure or surgery

    Laparoscopic sleeve gastrectomy is performed via 60 mm linear stapler (Endo GIATM Ultra, Covidien) .

Study groups in NCT03982823
Study groupRoleWhat they receive
Hand-Sewn Sleeve GastrectomyExperimentalNot described
Receives: Procedure: Hand-Sewn Sleeve Gastrectomy
Stapled Sleeve GastrectomyActive comparatorNot described
Receives: Procedure: Stapled Sleeve Gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Volume of intraoperative blood loss

    Intraoperative blood loss depending on duration of the operation (10-190 cc)

    Measured: Depending on duration of the operation (60-300 mins)

  2. Duration of the operation

    Operating time is compared between hand-sewn and stapled group

    Measured: Depending on the type of the operation (60-300 mins)

Secondary outcomes (2)
  1. Length of hospital stay

    Postoperative length of hospital stay

    Measured: 3-10 days

  2. Presence of postoperative complications

    leakage, peritonitis, gastrointestinal haemorrhage

    Measured: 3-13 days after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2019
  2. Study start1 May 2014
  3. Primary completion31 Dec 2014
  4. Study completion31 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Stapled Sleeve Gastrectomy Group and Hand-Sewn Sleeve Gastrectomy Group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03982823
Sponsor's protocol ID
2014/33
Status last verified
Jun 2019
First submitted
23 May 2019
Last updated
12 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Hand-Sewn Sleeve Gastrectomy and Stapled Sleeve Gastrectomy in people with Morbid Obesity, run by Inonu University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volume of intraoperative blood loss (time frame: Depending on duration of the operation (60-300 mins)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.

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